(2 days)
The Hemashield Platinum vascular grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Not Found
The provided text describes a Special 510(k) submission for a device modification, not a study proving a device meets acceptance criteria through performance evaluation. The submission focuses on demonstrating substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a legally marketed device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.
Here's why and what information is available:
- Focus of the Document: The core of this document is a 510(k) premarket notification. These notifications primarily aim to show that a new device is "substantially equivalent" to a predicate device already on the market. This often means demonstrating identical or very similar characteristics and performance.
- Lack of Acceptance Criteria and Performance Data: The document states that the "Hemashield Platinum grafts are different from the Hemashield Gold grafts only in the label claim for permeability." All other aspects are listed as "identical." This implies that the modification did not necessitate new performance studies against specific acceptance criteria for most features, as they are considered identical to a previously approved device.
- Summary of Substantial Equivalence: The document explicitly lists the following similarities between the modified device and the predicate device, which serve as the basis for claiming substantial equivalence rather than new performance data:
- Identical indications for use
- Identical labeling
- Identical manufacturing process flow
- Identical operating principle
- Incorporate identical materials
- Have the identical shelf-life (5 years)
- Are packaged and sterilized using identical packaging materials and processes
To directly answer your request based only on the provided text, I must state that the information is not available. The document does not describe a study with acceptance criteria and device performance in the way you've outlined.
Here's a breakdown of why each specific point you requested cannot be fulfilled by this document:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on declaring identity with a predicate device for most specifications and a specific difference in label claim for permeability, without providing quantitative performance data against laid-out acceptance criteria.
- Sample sized used for the test set and the data provenance: Not present. No specific test set or study data are detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. There is no mention of expert involvement in establishing ground truth for a test set.
- Adjudication method for the test set: Not present. No test set is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant and not present. This is a medical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant and not present. This is a vascular graft, not a software algorithm.
- The type of ground truth used: Not present, as no new performance study generating ground truth is described.
- The sample size for the training set: Not present, as no computational model requiring a training set is described.
- How the ground truth for the training set was established: Not present.
In summary, this document is a regulatory submission for a device modification based on substantial equivalence, not a performance study report.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”